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Health Sciences › Medicine › Cardiology and Cardiovascular Medicine
Effect of intermittent fasting after ST-elevation myocardial infarction on left ventricular function: study protocol of a pilot randomised controlled trial (INTERFAST-MI)
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Conflicts of Interest
Identified Weaknesses
Rating Explanation
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Paper Summary
Paperzilla title
Fasting After a Heart Attack: The 'Are We Even Able To Do This?' Protocol
This paper is a protocol outlining a pilot randomized controlled trial (INTERFAST-MI) to investigate the feasibility and safety of intermittent fasting in patients who have recently experienced a severe heart attack. The study aims to gather data on protocol adherence, recruitment rates, and preliminary effects on heart function (left ventricular ejection fraction) to inform the design and sample size calculation for a larger, definitive clinical trial. Key limitations, such as a small sample size and lack of blinding, are acknowledged as inherent to its pilot study design.
Possible Conflicts of Interest
None identified. The study is supported by the German Heart Research Foundation, a non-commercial entity.
Identified Weaknesses
Study Protocol, Not Findings
This paper is a study protocol, meaning it describes *how* the research will be conducted, not the results or findings. Therefore, it does not provide any clinical outcomes or efficacy data on intermittent fasting after myocardial infarction.
Pilot Study with Limited Power
The study is a pilot, non-confirmatory trial with a small sample size (48 patients, 24 per group) and a statistical power of 60%. This design is suitable for assessing feasibility and calculating sample size for a future full-scale trial but will not yield results that can be reliably interpreted for clinical efficacy.
Lack of Standardisation in Fasting Periods
Participants are allowed to choose their exact fasting periods, which, while improving compliance, introduces variability and may disguise the true effects of intermittent fasting due to a lack of standardization across the intervention group.
No Blinding
The nature of the intervention (intermittent fasting) precludes blinding of participants and researchers. This can introduce experimental bias from participants' expectations (placebo effect) and observers' effects, potentially influencing subjective outcomes, such as health-related quality of life assessments.
Exclusion of Patients with Diabetes on Insulin/Sulfonylurea
Patients with diabetes mellitus treated with insulin or sulfonylurea are excluded due to the risk of severe adverse events. This limits the generalizability of any future findings to a significant portion of the patient population who might also experience myocardial infarction.
Rating Explanation
This is a well-structured and clearly articulated protocol for a pilot study, which is a necessary step in scientific research. It transparently outlines its design, objectives (feasibility, safety, sample size calculation), and limitations. The rating reflects that, as a protocol, it is sound, but its scope is intentionally limited and not designed to provide definitive clinical outcomes.
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Topic Hierarchy
File Information
Original Title:
Effect of intermittent fasting after ST-elevation myocardial infarction on left ventricular function: study protocol of a pilot randomised controlled trial (INTERFAST-MI)
File Name:
e050067.full.pdf
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File Size:
0.32 MB
Uploaded:
October 12, 2025 at 07:46 PM
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